SAFC expands US high-potency pharma facility

29 August 2007 23:21[Source: ICIS news]

NEW YORK (ICIS news)--Sigma-Aldrich Fine Chemicals (SAFC) will invest $4.5m (€3.3m) to expand its high-potency active pharmaceutical ingredient (HPAPI) Wisconsin facility in Madison, the company said on Wednesday.

Commissioning was expected in early 2008, company officials said on Wednesday.

Two 400-litre reactors and two 100-litre portable jacketed reactors are to be added to a 1,200 square-foot dedicated, large-scale GMP kilo lab. The addition will enable larger-scale chromatography for process purification, catering to future business requirements.

For solid-form testing and analysis, SAFC Pharma has installed and qualified a Bruker D8 Advance X-ray Diffractometer in a new dedicated analytical laboratory, providing US customers with on-site cGMP and XRPD analysis of potent compounds.

Data analysis and evaluation are to be performed at SAFC Pharmorphix in the ?xml:namespace>UK, which SAFC acquired in mid 2006. Pharmorphix, which specialises in solid-form research, is completing its own multiphase, $1.2m expansion programme.

"As regulatory requirements align with the increasing complexity of drugs, solid-form testing, analysis and optimization are becoming key elements in the drug development process,” said Frank Wicks, SAFC president.